Evaluation of the Efficacy of a New Specific Infant Formula With a Prebiotic and Probiotics in Case of Functional Constipation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Functional Constipation
- Sponsor
- United Pharmaceuticals
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Hard stool consistency or painful defecation
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This study aims to assess the clinical efficacy, safety and tolerance of a new formula containing a prebiotic and a mix of probiotics in the specific population of infants suffering from functional constipation through a superiority, double-blind, randomized, placebo-controlled trial.
Detailed Description
The study comprises a selection period of 1 week where the eligibility of the infant to participate in the study will be evaluated. Once his/her participation is confirmed, the tested formula will be compared to a standard formula during a 2-month study period followed by an optional follow-up period of 2 months where only the tested formula will be used.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infants having completed the selection period and still compliant with non-selection criteria
- •Infants being constipated according to modified Rome IV criteria based on information recorded in parents' diary during the week preceding visit V0 (inclusion visit)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Hard stool consistency or painful defecation
Time Frame: 30 days
Proportion of hard or painful stools per total number of spontaneous bowel movements by participant. A spontaneous bowel movement is defined as described in outcome 2. Stool consistency will be evaluated based on the Brussels Infant and Toddler Stool Scale (BITSS). BITSS is a reliable instrument to assess stools of non-toilet trained children. It consists of color photographs of nappies containing stools from infants and toddlers categorized as hard, formed, loose, or watery (Huysentruyt et al., 2019). The consistency and painful defecation of each stool will be assessed by parents at Day 30.
Secondary Outcomes
- Painful defecation(30, 60, 90 and 120 days)
- Excessive stool retention(30, 60, 90 and 120 days)
- Treatment success(30, 60, 90 and 120 days)
- Weight(30, 60, 90 and 120 days)
- BMI(30, 60, 90 and 120 days)
- Rescue medication use(30, 60, 90 and 120 days)
- Stool consistency(30, 60, 90 and 120 days)
- Large diameter stools(30, 60, 90 and 120 days)
- Height(30, 60, 90 and 120 days)
- Sleep time satisfaction(30, 60, 90 and 120 days)
- Gut microbiota composition(0 and 60 days)
- Short-chain fatty acids (SCFAs)(0 and 60 days)
- Total and spontaneous defecation frequency(30, 60, 90 and 120 days)
- Head circumference(30, 60, 90 and 120 days)
- Nutritional status(0 and 60 days)
- Crying time(30, 60, 90 and 120 days)
- Parents' quality of life (QoL)(30, 60, 90 and 120 days)
- Adverse events(Through study completion, i.e. 67 days or 127 days if participation to the optional follow-up period)
- Regurgitations(30, 60, 90 and 120 days)
- Sleep quality(30, 60, 90 and 120 days)
- Parents' satisfaction(30, 60, 90 and 120 days)